drugset / Trial / NCT05226013
Tolerance, Pharmacokinetics / Pharmacodynamics (PK / PD) and Immunogenicity of Pegylated Uric Acid Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers
RandomizedSequentialDouble-blindTreatment
Summary
A randomized, double-blind, placebo-controlled study of tolerance, pharmacokinetic / pharmacodynamics (PK / PD) and immunogenicity of single administration of PEG uric oxidase for injection in healthy adults and hyperuricemia volunteers.
Timeline
- Start
- 2021-12-08
- Primary completion
- 2022-12-01
- Completion
- 2023-04-01
Publications
- Sun F, Zhang J, Yan Z, Yu Q, Wang P, He Y, Liu M, Huang B, Fang L, Xu Y, Fu Y, Gao X, Li C, Cao Y. Efficacy and safety of PEGylated uricase in healthy adults and patients with hyperuricaemia: A phase I, randomized, double-blind, dose-escalation, placebo-controlled trial. Diabetes Obes Metab. 2025 Sep;27(9):4892-4902. doi: 10.1111/dom.16532. Epub 2025 Jun 25.
- Sun F, Wang C, Xu Y, Lin P, Cao Y, Zhang J, Li X, Jiang X, Fu Y, Cao Y. Randomized, Double-Blind, Placebo-Controlled, Phase I, Dose- Escalation Study to Evaluate the Tolerance, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PEGylated Urate Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers: Study Protocol. Diabetes Metab Syndr Obes. 2023 Dec 28;16:4263-4268. doi: 10.2147/DMSO.S429114. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEGylated uricase | Protein / enzyme biologic | 0.5 mg | Intravenous |
| Subject | PEGylated uricase | Protein / enzyme biologic | 1 mg | Intravenous |
| Subject | PEGylated uricase | Protein / enzyme biologic | 2 mg | Intravenous |
| Subject | PEGylated uricase | Protein / enzyme biologic | 4 mg | Intravenous |
| Subject | PEGylated uricase | Protein / enzyme biologic | 8 mg | Intravenous |
| Subject | PEGylated uricase | Protein / enzyme biologic | 12 mg | Intravenous |
Indications
No indication recorded.